Docket Number:
FDA-2019-N-6084
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The purpose of this guidance is to provide the Food and Drug Administration’s (FDA’s) current recommendations regarding the overall evaluation of safety for the development of drugs and biologics indicated for improvement of glycemic control in patients with type 2 diabetes mellitus. The recommendations in this guidance reflect discussions at the Endocrinologic and Metabolic Drugs Advisory Committee meeting held October 24–25, 2018, that considered FDA’s review of cardiovascular (CV) outcome trials (CVOTs).

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All written comments should be identified with this document's docket number: FDA-2019-N-6084.